Ag groups file additional comments on FMD vaccine

Zoetis seeks approval to bring live Foot and Mouth Disease virus into the U.S. mainland to develop a vaccine.


Jacqui Fatka, BEEF Magazine

Jan 07, 2021


Livestock industry groups are supportive of USDA’s proposal to adopt new technology in Foot and Mouth Disease vaccines, as well as the establishment of a robust FMD vaccine bank. In new comments submitted Jan. 4, additional comments were made by the National Pork Producers Council and the U.S. Cattlemen’s Association on a Zoetis-manufactured vaccine on the review process and the manufacturing of the vaccine domestically. 


An FMD outbreak within the United States could result in $14 billion in losses, calculated to include both farm income and the effect on consumers and international trade relations.


On July 14, 2020, USDA Animal and Plant Health Inspection Service published in the Federal Register a notice and request for information on a petition submitted by Zoetis, Inc., a U.S. vaccine manufacturer, seeking approval to manufacture within the continental United States a vaccine produced using a leaderless strain of the FMD virus. A leaderless virus lacks part of the genetic code (the leader) critical for determining virulence in a host.


USDA issued a permit to Zoetis to bring attenuated live FMD virus into the mainland United States for the purpose of developing a vaccine.


The FMD virus strain brought into the United States under permit was genetically modified by removing the leader protease gene, rendering the strain incapable of becoming infectious, pathogenic, contagious, or of producing clinical or subclinical signs of FMD. This modification makes the virus unable to reacquire its infectious abilities through mutation. Zoetis also introduced unique restriction enzyme sites into the genome for emerging vaccine strain development, as well as markers that allow for differentiation of infected from vaccinated animals.


Stakeholders note the notice and petition did not provide enough data to support a determination that the leaderless virus is not a live virus and that it poses no risk of causing FMD infection in animals. To address those concerns, APHIS issued a Risk Assessment Summary of the FMD-LL3B3D A24 Cruzeiro Vaccine, supporting the safety of the leaderless FMD virus and its use in manufacturing FMD vaccine and reopened the comment period.


USDA reopened the comment period on the risk assessment to provide commenters with additional scientific information supporting its determination that the leaderless virus strain from which Zoetis, Inc. intends to produce FMD vaccine in the United States poses no risk of causing FMD infection in animals.


Evaluating FMD risk ...